Covid-19NCT04378712
Hydrogen/Oxygen Mixed Gas Inhalation for Coronavirus Disease 2019 (COVID-19)
A study testing Hydrogen Oxygen Generator with Nebulizer and Standard-of-care in people with Covid-19 and Hydrogen/Oxygen Mixed Gas, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
This was a randomized, multi-center, open-label clinical trial. Eligible patients were recruited from seven hospitals in China. On the basis of standard-of-care, patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid-19, Hydrogen/Oxygen Mixed Gas, Dyspnea
- What is being tested?
- Hydrogen Oxygen Generator with Nebulizer and Standard-of-care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2020to 23 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lab-confirmed Covid-19 aged 18 to 75 years.
- Had dyspnea both on hospital admission and at enrollment.
- The patients volunteered to participate in this study and signed the informed consent
Who cannot join
- Have other systemic diseases other than COVID-19 -- a disease that, according to the investigator's judgment, might increase the risk of developing adverse outcomes or affect the outcome measures after participation in the study.
- Women who are pregnant or breastfeeding or plan to be pregnant during the study.
- Subjects with one of the following respiratory diseases:
- Subjects in critical or unstable conditions. Critical (meeting any of the following symptoms): 1. Respiratory failure occurs and mechanical ventilation is needed; 2. Shock occurs; 3. Other organ failure, ICU monitoring and treatment is needed.
- Having immunosuppressive diseases (HIV), severe neurological disease affecting upper respiratory tract control, or other risk factors that the investigator believes can cause a significant risk of pneumonia in subjects.
- Subjects with mental disorder and cognitive impairment.
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- Subjects who do not follow the study steps.
- Patients with mental retardation, poor motivation, drug abuse (including drugs and alcohol) or other disease history restricting the effectiveness of informed consent in this study.
- Use of antioxidants, including large doses of vitamin C and vitamin E.
- Subjects who are not suitable for participation in this study in the judgment of investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
About this study
Official title: Effects of Hydrogen/Oxygen Mixed Gas Inhalation for Patients With Coronavirus Disease 2019 (COVID-19) Who Had Dyspnea: A Multicenter, Open-label Clinical Trial
This was a randomized, multi-center, open-label clinical trial. Eligible patients were recruited from seven hospitals in China. On the basis of standard-of-care, patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge. Patients in control group received standard-of-care (consisting of oxygen therapy) alone until discharge.
Read the detailed description
This was a randomized, multi-center, open-label clinical trial. Eligible patients were recruited from seven hospitals in China. On the basis of standard-of-care, patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge. Patients in control group received standard-of-care (consisting of oxygen therapy) alone until discharge. Clinical assessments included the five-category ordinal scale, four-category ordinary scale of dyspnea, coughing, chest distress and chest pain (0: None; 1: Mild; 2: Moderate; 3: Severe; 4: Very severe) and adverse events, performed on admission, at enrollment, at day 2 and 3 after randomization, and the day before discharge. The primary endpoint was the proportion of patients with improved disease severity (by at least one scale). Secondary endpoints comprised the change from baseline in oxygen saturation and symptom scales.
- Conditions
- Covid-19, Hydrogen/Oxygen Mixed Gas, Dyspnea
- Being tested
- Hydrogen Oxygen Generator with Nebulizer, Standard-of-care
- Keywords
- Covid-19, Hydrogen/oxygen mixed gas, Dyspnea
- Medical subject headings
- COVID-19, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen Oxygen Generator with NebulizerDevice
Patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge.
Standard-of-careOther
Standard-of-care consisted of the supportive therapies (including oxygen therapy) recommended by the Chinese National Health Commission
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | H2-O2 (66% hydrogen; 33% oxygen) inhalation. Patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge. Receives: Device: Hydrogen Oxygen Generator with Nebulizer; Other: Standard-of-care |
| Control Group | Other | Usual care referred to the standard-of-care (including oxygen therapy) recommended by Chinese National Health Commission. Receives: Other: Standard-of-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with improved disease severity at day 2
The proportion of patients with improved disease severity (by at least one scale) at day 2
Measured: from baseline to day 2
The proportion of patients with improved disease severity at day 3
The proportion of patients with improved disease severity (by at least one scale) at day 3
Measured: from baseline to day 3
The proportion of patients with improved disease severity at the day before hospital discharge
The proportion of patients with improved disease severity (by at least one scale) at the day before hospital discharge
Measured: up to 14 days (from baseline to the day before hospital discharge)
Secondary outcomes (15)
The change from baseline in oxygen saturation at day 2.
The change from baseline in oxygen saturation at day 2.
Measured: from baseline to day 2
The change from baseline in oxygen saturation at day 3.
The change from baseline in oxygen saturation at day 3.
Measured: from baseline to day 3
The change from baseline in oxygen saturation at the day before hospital discharge
The change from baseline in oxygen saturation at the day before hospital discharge.
Measured: up to 14 days (from baseline to the day before hospital discharge)
The change from baseline in dyspnea scale at day 2.
The change from baseline in dyspnea scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2.
Measured: from baseline to day 2
The change from baseline in dyspnea scale at day 3.
The change from baseline in dyspnea scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3.
Measured: from baseline to day 3
The change from baseline in dyspnea scale at the day before hospital discharge.
The change from baseline in dyspnea scale (ranging from 0-4, with higher scores indicating severer outcomes) at the day before hospital discharge.
Measured: up to 14 days (from baseline to the day before hospital discharge)
The change from baseline in cough scale at day 2
The change from baseline in cough scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2
Measured: from baseline to day 2
The change from baseline in cough scale at day 3
The change from baseline in cough scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3
Measured: from baseline to day 3
The change from baseline in cough scale at the day before hospital discharge
The change from baseline in cough scale (ranging from 0-4, with higher scores indicating severer outcomes) at the day before hospital discharge
Measured: up to 14 days (from baseline to the day before hospital discharge)
The change from baseline in chest pain scale at day 2.
The change from baseline in chest pain scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2.
Measured: from baseline to day 2
The change from baseline in chest pain scale at day 3.
The change from baseline in chest pain scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3.
Measured: from baseline to day 3
The change from baseline in chest pain scale at the day before hospital discharge.
The change from baseline in chest pain scale (ranging from 0-4, with higher scores indicating severer outcomes) at the day before hospital discharge.
Measured: up to 14 days (from baseline to the day before hospital discharge)
The change from baseline in chest distress scale at day 2.
The change from baseline in chest distress scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 2.
Measured: from baseline to day 2
The change from baseline in chest distress scale at day 3.
The change from baseline in chest distress scale (ranging from 0-4, with higher scores indicating severer outcomes) at day 3.
Measured: from baseline to day 3
The change from baseline in chest distress scale at the day before hospital discharge.
The change from baseline in chest distress scale (ranging from 0-4, with higher scores indicating severer outcomes) at the day before hospital discharge.
Measured: up to 14 days (from baseline to the day before hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start21 Jan 2020
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijie Guan, Guangzhou Institute of Respiratory Disease
- Investigators
- Wei-jie Guan, PhD, Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378712
- Sponsor's protocol ID
- JT202005LZ
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
PubMed 32167524Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
PubMed 32085846Zhou ZQ, Zhong CH, Su ZQ, Li XY, Chen Y, Chen XB, Tang CL, Zhou LQ, Li SY. Breathing Hydrogen-Oxygen Mixture Decreases Inspiratory Effort in Patients with Tracheal Stenosis. Respiration. 2019;97(1):42-51. doi: 10.1159/000492031. Epub 2018 Sep 18.
PubMed 30227423Morgan SE, Vukin K, Mosakowski S, Solano P, Stanton L, Lester L, Lavani R, Hall JB, Tung A. Use of heliox delivered via high-flow nasal cannula to treat an infant with coronavirus-related respiratory infection and severe acute air-flow obstruction. Respir Care. 2014 Nov;59(11):e166-70. doi: 10.4187/respcare.02728. Epub 2014 Aug 12.
PubMed 25118308Kneyber MC, van Heerde M, Markhorst DG, Plotz FB. Mechanical ventilation with heliox decreases respiratory system resistance and facilitates CO2 removal in obstructive airway disease. Intensive Care Med. 2006 Oct;32(10):1676-7. doi: 10.1007/s00134-006-0348-6. Epub 2006 Aug 23. No abstract available.
PubMed 16927073
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hydrogen/Oxygen Mixed Gas Inhalation for Patients With Coronavirus Disease 2019 (COVID-19) Who Had Dyspnea: A Multicenter, Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT04378712
- Acronym / sponsor ID
- JT202005LZ
- Conditions
- Covid-19, Hydrogen/Oxygen Mixed Gas, Dyspnea
- Keywords
- Covid-19, Hydrogen/oxygen mixed gas, Dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomized, multi-center, open-label clinical trial. Eligible patients were recruited from seven hospitals in China. On the basis of standard-of-care, patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge. Patients in control group received standard-of-care (consisting of oxygen therapy) alone until discharge.
Detailed description
This was a randomized, multi-center, open-label clinical trial. Eligible patients were recruited from seven hospitals in China. On the basis of standard-of-care, patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge. Patients in control group received standard-of-care (consisting of oxygen therapy) alone until discharge. Clinical assessments included the five-category ordinal scale, four-category ordinary scale of dyspnea, coughing, chest distress and chest pain (0: None; 1: Mild; 2: Moderate; 3: Severe; 4: Very severe) and adverse events, performed on admission, at enrollment, at day 2 and 3 after randomization, and the day before discharge. The primary endpoint was the proportion of patients with improved disease severity (by at least one scale). Secondary endpoints comprised the change from baseline in oxygen saturation and symptom scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Hydrogen Oxygen Generator with Nebulizer, Other: Standard-of-careH2-O2 (66% hydrogen; 33% oxygen) inhalation. Patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge. |
| Control Group | Other | Other: Standard-of-careUsual care referred to the standard-of-care (including oxygen therapy) recommended by Chinese National Health Commission. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with lab-confirmed Covid-19 aged 18 to 75 years.
- Had dyspnea both on hospital admission and at enrollment.
- The patients volunteered to participate in this study and signed the informed consent
Key exclusion criteria (10 listed)
- Have other systemic diseases other than COVID-19 -- a disease that, according to the investigator's judgment, might increase the risk of developing adverse outcomes or affect the outcome measures after participation in the study.
- Women who are pregnant or breastfeeding or plan to be pregnant during the study.
- Subjects in critical or unstable conditions. Critical (meeting any of the following symptoms): 1. Respiratory failure occurs and mechanical ventilation is needed; 2. Shock occurs; 3. Other organ failure, ICU monitoring and treatment is needed.
- Having immunosuppressive diseases (HIV), severe neurological disease affecting upper respiratory tract control, or other risk factors that the investigator believes can cause a significant risk of pneumonia in subjects.
- Subjects with mental disorder and cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen Oxygen Generator with NebulizerPatients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge. | Device | Intervention Group |
| Standard-of-careStandard-of-care consisted of the supportive therapies (including oxygen therapy) recommended by the Chinese National Health Commission | Other | Control Group, Intervention Group |
Primary outcome
The proportion of patients with improved disease severity at day 2
Time frame: from baseline to day 2
The proportion of patients with improved disease severity (by at least one scale) at day 2
The proportion of patients with improved disease severity at day 3
Time frame: from baseline to day 3
The proportion of patients with improved disease severity (by at least one scale) at day 3
The proportion of patients with improved disease severity at the day before hospital discharge
Time frame: up to 14 days (from baseline to the day before hospital discharge)
The proportion of patients with improved disease severity (by at least one scale) at the day before hospital discharge
15 secondary outcomes
The change from baseline in oxygen saturation at day 2.
Time frame: from baseline to day 2
The change from baseline in oxygen saturation at day 3.
Time frame: from baseline to day 3
The change from baseline in oxygen saturation at the day before hospital discharge
Time frame: up to 14 days (from baseline to the day before hospital discharge)
The change from baseline in dyspnea scale at day 2.
Time frame: from baseline to day 2
The change from baseline in dyspnea scale at day 3.
Time frame: from baseline to day 3
The change from baseline in dyspnea scale at the day before hospital discharge.
Time frame: up to 14 days (from baseline to the day before hospital discharge)
The change from baseline in cough scale at day 2
Time frame: from baseline to day 2
The change from baseline in cough scale at day 3
Time frame: from baseline to day 3
The change from baseline in cough scale at the day before hospital discharge
Time frame: up to 14 days (from baseline to the day before hospital discharge)
The change from baseline in chest pain scale at day 2.
Time frame: from baseline to day 2
The change from baseline in chest pain scale at day 3.
Time frame: from baseline to day 3
The change from baseline in chest pain scale at the day before hospital discharge.
Time frame: up to 14 days (from baseline to the day before hospital discharge)
The change from baseline in chest distress scale at day 2.
Time frame: from baseline to day 2
The change from baseline in chest distress scale at day 3.
Time frame: from baseline to day 3
The change from baseline in chest distress scale at the day before hospital discharge.
Time frame: up to 14 days (from baseline to the day before hospital discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Background: PubMed 32167524Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
- Background: PubMed 32085846Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.
- Background: PubMed 30227423Zhou ZQ, Zhong CH, Su ZQ, Li XY, Chen Y, Chen XB, Tang CL, Zhou LQ, Li SY. Breathing Hydrogen-Oxygen Mixture Decreases Inspiratory Effort in Patients with Tracheal Stenosis. Respiration. 2019;97(1):42-51. doi: 10.1159/000492031. Epub 2018 Sep 18.
- Background: PubMed 25118308Morgan SE, Vukin K, Mosakowski S, Solano P, Stanton L, Lester L, Lavani R, Hall JB, Tung A. Use of heliox delivered via high-flow nasal cannula to treat an infant with coronavirus-related respiratory infection and severe acute air-flow obstruction. Respir Care. 2014 Nov;59(11):e166-70. doi: 10.4187/respcare.02728. Epub 2014 Aug 12.
- Background: PubMed 16927073Kneyber MC, van Heerde M, Markhorst DG, Plotz FB. Mechanical ventilation with heliox decreases respiratory system resistance and facilitates CO2 removal in obstructive airway disease. Intensive Care Med. 2006 Oct;32(10):1676-7. doi: 10.1007/s00134-006-0348-6. Epub 2006 Aug 23. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-jie Guan, PhD principal investigator
Guangzhou Institute of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogen Oxygen Generator with Nebulizer and Standard-of-care in people with Covid-19 and Hydrogen/Oxygen Mixed Gas, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with improved disease severity at day 2 (time frame: from baseline to day 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04378712, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.